Any national additions and specifications can be found in the national Medical Devices Act.
The guidelines by the Medical Devices Coordination Group should be followed.
Any medical device may only be placed on the Estonian market or put into use if the device:
complies with the requirements in regulation (EU) 2017/745 or (EU) 2017/746 or is placed on the market in accordance with the transitional provisions in these regulations;
complies with the Medical Devices Act and other relevant legal acts.
Placing on the market of medical devices through EUDAMED
As of 26 May 2026, the European database on medical devices (EUDAMED) is mandatory for all economic operators. Manufacturers placing medical devices on the market must register themselves and their devices in EUDAMED before making products available on the EU market, including in Estonia. Registration and device information that was previously submitted to national databases for manufacturers is now done exclusively through EUDAMED.
Please refer to the sections below for details on which national obligations remain in force.
National notification obligations
Distributors
The obligation to notify of the distribution of medical devices is not affected by EUDAMED becoming mandatory. Pursuant to § 26 of the Estonian Medical Devices Act every actor who distributes in Estonia:
system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745;
IIa, IIb or III medical devices classified according to Regulation (EU) 2017/745 or Council Directive 93/42/EEC;
active implantable medical devices according to Council Directive 90/385/EEC;
class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746
shall notify the State Agency of Medicines within 10 days after distribution of the relevant medical device for the first time.
This obligation lies with the economic operator acting in the role of a distributor and notification will continue to be submitted via the national Medical Devices and Appliances Database (EMDDB).
The notification of Class I, Class A devices is recommended, but not mandatory.
Custom-made medical devices
Custom-made medical devices are not registered in EUDAMED. Accordingly, manufacturers of custom-made medical devices remain subject to a national notification obligation under § 26(3) of the Medical Devices Act:
Every undertaking who makes a custom-made medical device available on the market notifies the State Agency of Medicines of the intention to make such medical device available on the market at least 10 days prior to making such medical device available on the market.
Notifications to the State Agency of Medicines are made through the online Estonian Medical Devices and Appliances Database (EMDDB).
There are no fees for registration or adding medical devices to EMDDB.
With any questions or concerns please contact the Department of Medical Devices at [email protected].
Last updated: 03.06.2026
